An Eventful Week for Biosimilars

It has been an eventful week in the biosimilar world during a rather uneventful beginning to 2017. The next likely FDA decision on a biosimilar will not occur until reviews of Samsung Bioepis and Merck’s version of infliximab or Coherus Bioscience’s version of pegfilgrastim are completed sometime in the second quarter.

However, the biosimilar world is girding for the opening arguments April 26 in the Supreme Court’s hearings on the validity of the 180-day notification (exclusivity) period. To this end, the Biosimilar Council issued a lengthy amicus brief arguing cogently that Congress did not intend to provide 12.5 years of marketing exclusivity to biologic manufacturers. Several others have petitioned the court with similar arguments, including AARP and America’s Health Insurance Plan. In fact, I would be interested in reading an amicus brief in defense of the notification period.

The Biosimilar Council’s parent organization recognized an opportunity was opening wide, and decided to rename itself. The Generic Pharmaceutical Association is now officially the Association for Accessible Medicines.

The European Medicines Agency handed Celltrion the approval for the first biosimilar of an anticancer monoclonal antibody. Truxima™ is a biosimilar version of rituximab, which will compete against MabThera® (which is also marketed as Rituxan® in the US). Celltrion has partnered with Teva to market the biosimilar in the US, if and when the FDA approves the agent. Celltrion is yet to file for FDA approval. Two other monoclonal antibodies have been filed with the FDA for the direct treatment of cancer—trastuzumab (Mylan/Biocon) and bevacizumab (Amgen/Allergan), both of which are expected to yield FDA decisions in the latter half of 2017.

Finally, a study was published this week that highlighted the overall cost problem for the health care system—the price of cancer medications are persuading significant proportions of cancer survivors to skip their drugs or specifically request lower-cost alternatives. It is well known that cancer diagnoses are one of the most common reasons for medical bankruptcy. An earlier literature review of the financial implications of cancer reported that more than half of cancer survivors were in debt as a result of their cancer treatment, and roughly half of cancer survivors experienced some form of financial distress. These investigators stated that depending on the study, between 4% and 45% of these patients “did not adhere to recommended prescription medication because of cost.”